Pilot Feasibility Study of Psychosocial Support to Improve Well-being of Adults in Humanitarian Crises in Nepal

Depression Clinical Trial

— PM+  

Official title:

Pilot Feasibility Study of Focused Psychosocial Support to Improve the Psychosocial Well-being and Functioning of Adults Affected by Humanitarian Crisis in Nepal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359486
• Other study ID #: ERC.0002817
• Status: Completed
• Phase: N/A
• Start date: December 17, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: October 2018
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot feasibility study of group problem management plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by humanitarian crises. The current study will evaluate feasibility and acceptability of the intervention to determine procedures and content for a subsequent full trial using a cluster-randomized design of group problem management plus versus enhanced treatment as usual.

Description:

Counselling programmes used in many humanitarian settings are often non-specific with unknown efficacy and safety. Only a few interventions in humanitarian crises have been rigorously tested, and most studied interventions focused on posttraumatic stress disorder. Beyond posttraumatic stress disorder, individuals may have a range of problems including depression, anxiety, and not being able to do daily tasks necessary for survival and recovery. However, interventions are often limited since they tend to target only a single outcome, are usually of longer duration (8-16 sessions) or require professionals.

In low resourced settings interventions need to be short of duration, and be carried out by lay people in the communities to make them sustainable and feasible to implement on a broader scale. World Health Organization aims to develop a range of low-intensity scale-able psychological interventions that address these issues, as part of its mental health Gap Action Program. As a first step a simplified psychological intervention Problem Management Plus (PM+) has been developed. It has 4 core features that make the intervention suitable for low resourced setting exposed to adversities. First, it is brief intervention (5-sessions), delivered individually or in groups; second, it can be delivered by paraprofessionals (high school graduates with no mental health experience), using the principle of task shifting/ task sharing; third, it is designed as a trans-diagnostic intervention, addressing a range of client identified emotional (e.g. depression, anxiety, traumatic stress, general stress) and practical problems; fourth, it is designed for people in low-income country communities affected by any kind of adversity (e.g. violence, disasters), not just focusing on a single kind of adversity.

Recent PM+ trails in Pakistan and Kenya have indicated PM+ to be effective in diminishing depression and anxiety and improving people's functioning and self-selected, culturally relevant outcomes. In this project Group PM+ will be piloted in a district in Nepal, which was affected by the 2015 earthquakes in Nepal. The current pilot study will evaluate the acceptability and feasibility of Group PM+ in Nepal to informant a subsequent pragmatic cluster randomized controlled trial. This exploratory cluster randomized controlled trial (cluster randomized controlled trial) will be conducted to gather information about the feasibility, safety and delivery of the intervention in the Nepali community settings; and to identify issues around training, supervision and outcomes measures. This research strategy is informed by the United Kingdom Medical Research Council framework for the development of complex interventions, which recognizes iterations of: a) Intervention Development; b) Feasibility and Piloting; c) Evaluation; and d) Implementation. This framework recommends to first conduct feasibility and randomized pilot studies before conducting large scale trials. In this way possible problems of acceptability, compliance, delivery of the intervention, recruitment and retention can be detected before the large definitive scale trail is conducted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. score >2 on General Health Questionnaire (dichotomous item scoring method)

2. score >16 on World Health Organization Disability Assessment Scale

Exclusion Criteria:

1. Presence of a severe mental disorder (e.g., psychosis)

2. Alcohol use disorder (score >16 on the alcohol use disorders identification test (AUDIT)

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Group problem management plus
Low intensity group psychological intervention including stress management, behavioral activation, problem solving, and strengthening social support
• Enhanced treatment as usual
Referral to primary care workers trained in mental health Gap Action Program Implementation Guide

Locations

Country	Name	City	State
Nepal	Transcultural Psychosocial Organization (TPO) Nepal	Kamalamai	Sindhuli

Sponsors (5)

Lead Sponsor	Collaborator
George Washington University	Duke University, King's College London, Transcultural Psychosocial Organization Nepal, World Health Organization

Country where clinical trial is conducted

Nepal, 

References & Publications (9)

Bryant RA, Schafer A, Dawson KS, Anjuri D, Mulili C, Ndogoni L, Koyiet P, Sijbrandij M, Ulate J, Harper Shehadeh M, Hadzi-Pavlovic D, van Ommeren M. Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial. PLoS Med. 2017 Aug 15;14(8):e1002371. doi: 10.1371/journal.pmed.1002371. eCollection 2017 Aug. — View Citation

Chiumento A, Hamdani SU, Khan MN, Dawson K, Bryant RA, Sijbrandij M, Nazir H, Akhtar P, Masood A, Wang D, van Ommeren M, Rahman A. Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial. Trials. 2017 Apr 26;18(1):190. doi: 10.1186/s13063-017-1905-8. — View Citation

Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. — View Citation

Dawson KS, Schafer A, Anjuri D, Ndogoni L, Musyoki C, Sijbrandij M, van Ommeren M, Bryant RA. Feasibility trial of a scalable psychological intervention for women affected by urban adversity and gender-based violence in Nairobi. BMC Psychiatry. 2016 Nov 18;16(1):410. — View Citation

Hamdani SU, Ahmed Z, Sijbrandij M, Nazir H, Masood A, Akhtar P, Amin H, Bryant RA, Dawson K, van Ommeren M, Rahman A, Minhas FA. Problem Management Plus (PM+) in the management of common mental disorders in a specialized mental healthcare facility in Pakistan; study protocol for a randomized controlled trial. Int J Ment Health Syst. 2017 Jun 8;11:40. doi: 10.1186/s13033-017-0147-1. eCollection 2017. Erratum in: Int J Ment Health Syst. 2018 Sep 27;12:53. — View Citation

Khan MN, Hamdani SU, Chiumento A, Dawson K, Bryant RA, Sijbrandij M, Nazir H, Akhtar P, Masood A, Wang D, Wang E, Uddin I, Ommeren MV, Rahman A. Evaluating feasibility and acceptability of a group WHO trans-diagnostic intervention for women with common mental disorders in rural Pakistan: a cluster randomised controlled feasibility trial. Epidemiol Psychiatr Sci. 2017 Jul 10:1-11. doi: 10.1017/S2045796017000336. [Epub ahead of print] — View Citation

Rahman A, Riaz N, Dawson KS, Usman Hamdani S, Chiumento A, Sijbrandij M, Minhas F, Bryant RA, Saeed K, van Ommeren M, Farooq S. Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict-affected Pakistan. World Psychiatry. 2016 Jun;15(2):182-3. doi: 10.1002/wps.20312. — View Citation

Sijbrandij M, Bryant RA, Schafer A, Dawson KS, Anjuri D, Ndogoni L, Ulate J, Hamdani SU, van Ommeren M. Problem Management Plus (PM+) in the treatment of common mental disorders in women affected by gender-based violence and urban adversity in Kenya; study protocol for a randomized controlled trial. Int J Ment Health Syst. 2016 May 31;10:44. doi: 10.1186/s13033-016-0075-5. eCollection 2016. Erratum in: Int J Ment Health Syst. 2018 Oct 12;12:55. — View Citation

Sijbrandij M, Farooq S, Bryant RA, Dawson K, Hamdani SU, Chiumento A, Minhas F, Saeed K, Rahman A, van Ommeren M. Problem Management Plus (PM+) for common mental disorders in a humanitarian setting in Pakistan; study protocol for a randomised controlled trial (RCT). BMC Psychiatry. 2015 Oct 1;15:232. doi: 10.1186/s12888-015-0602-y. Erratum in: BMC Psychiatry. 2018 Oct 15;18(1):331. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression - Patient Health Questionnaire	9-item measure of depression symptoms, culturally and clinically validated in Nepal	1 week post-intervention
Secondary	Daily functioning - World Health Organization Disability Assessment Scale	12-item assessment ability to engage in daily activities, previously used in numerous studies in Nepal	1 week post-intervention
Secondary	General psychological distress - General Health Questionnaire	12-item measure of general psychological distress, previously validated for use in Nepal	1 week post-intervention
Secondary	Posttraumatic Stress Disorder - Posttraumatic Stress Disorder Checklist	8-tem measure of post-traumatic stress symptoms validated for use in Nepal	1 week post-intervention
Secondary	Personalized Measure of Distress - Psychological Outcome Profiles	3-item measure of personalized distress and problems, 4-items post-treatment	1 week post-intervention
Secondary	Culture-specific general psychological distress - Nepali Psychosocial and Mental Health Problems	5-item measure of somatic symptoms of psychosocial and mental health problems validated in Nepal	1 week post-intervention
Secondary	Reducing Tension Checklist for Problem Management Plus Skills	12-item measure of behavioral and psychosocial skills related to coping mechanisms	1 week post-intervention

External Links

•   Problem management plus individual manual distributed by the World Health Organization